02/03/2004 Speech by John D. Graham

John D. Graham, Ph.D., Administrator
Office of Information and Regulatory Affairs
Office of Management and Budget
Executive Office of the President

Toxicology
Forum
Washington DC

February 3, 2004

Slickspot
peppergrass, the age 60 rule, barium, the Northern Goshawk, anthraquinone,
and atrazine. One would not normally expect to mention these topics in
the same discussion, let alone the same sentence. However, thanks to the
Information Quality Act, these subjects are now linked. The Fish and Wildlife
Service received a correction request regarding its proposed listing of
slickspot peppergrass (a small plant that occurs in sage-brush areas in
Idaho) as an endangered species; the Federal Aviation Administration received
a correction request about a rule that says pilots are prohibited from
flying commercially at age 60 and beyond; the Office of Research and Development,
at EPA, received a correction request about the safe level for exposure
to barium (a naturally occurring metal); the Forest Service received a
correction request regarding habitat management for the Northern Goshawk
(a bird from the hawk family that lives in forests); the National Toxicology
Program received a correction request about preliminary test results for
anthraquinone (a chemical used as an intermediate in the production of
dyes, other organics, birdseed, and other areas); and the Office of Pesticides,
Pollution and Toxic Substances, at EPA, received a correction request
regarding the potential for endocrine disruption of atrazine (a herbicide
frequently used by corn growers). These are just a few examples of the
breadth of topics that the Information Quality Act has touched upon.

It is my
pleasure to be here today to speak with you about the Information Quality
Act. The federal agencies have just completed the first year of implementing
this new law, and I am happy to share with you what we have learned during
this first year.

HISTORY

The story
began towards the end of the previous Administration, when Congress enacted
a law requiring OMB to develop procedures to improve the quality of information
disseminated by federal agencies. The law was enacted as a rider to our
appropriations bill1. Informally known as the "Information
Quality Act", the law does two main things: (1) it requires the agencies
to develop pre-dissemination procedures that will ensure the quality of
information disseminated by the agencies. (2) it requires agencies to
develop an administrative mechanism whereby affected parties can request
that agencies correct poor quality information. If the public is dissatisfied
with the initial agency response to a complaint, an appeal opportunity
is provided by the Agencies.

The Bush
Administration is committed to vigorous implementation of the Information
Quality Law. We believe it provides an excellent opportunity to enhance
both the competence and accountability of government.

PERCEPTIONS
AND REALITIES

OMB has heard
many concerns about the Information Quality Law and the implementation
process. I would like to share with you some of those concerns, as well
as the perceptions and the realities that have come to be associated with
them.

Perception:Agencies
will be inundated with requests for corrections.

Reality:
The strong belief that certain agencies would be overwhelmed by the volume
of complaints was one of the most common early perceptions. To many peoples'
surprise, that has not been the case. In total, the agencies have received
about several dozen complaints that appear to be stimulated by the Information
Quality Law. There has been a large volume of complaints (almost 5000)
to FEMA regarding requests for map correction changes as part of the national
flood insurance program, and a large volume of requests (about 100) to
the Federal Motor Carrier Safety Administration (FMCSA) regarding the
incorrect reporting of individual accidents. However, these kinds of complaints
were commonplace prior to the Information Quality Law. Of the approximately
30 distinctive complaints, EPA, HHS, Interior and USDA have received most
of the complaints, and a few have gone to Commerce, Education, and OSTP
(the White House Office of Science and Technology Policy).

Perception:
The Information Quality correction process is a tool only for industry.

Reality:
I'm pleased to report that the Information Quality Act has been used by
virtually all segments of the political spectrum. Complaints have been
filed by private citizens, corporations, farm groups, trade organizations,
both liberal and conservative non-governmental organizations (for example:
the Competitive Enterprise Institute (CEI), Wrestling Coaches Association,
Sierra Club, John Muir Society, and Public Employees for Environmental
Responsibility), and even other government agencies (an Air Force complaint
to Fish and Wildlife). The Information Quality Law has even been used
by four U.S. Senators (a joint complaint by Senators Boxer, Jeffords,
Lautenberg and Sarbanes to EPA).

Perception: The Information Quality Law will result in slowing down the regulatory
process at the agencies.

Reality: We can also report that to date, neither OMB, nor our engaged stakeholders,
has noticed or commented upon any slowdown of the regulatory process.
Twice a year the agencies provide OMB and the public with their regulatory
agendas. This is a compendium of rules that the agencies intend to take
action on within the next 12 months. This acts as a management tool for
the agencies and lets OMB and stakeholders know what agencies are planning.
Once a rulemaking arrives at OMB, through our tracking mechanisms we know
how quickly the rule moves through the review process. Additionally, on
the OIRA website the public can see when a rule arrives, and when it is
cleared. To our knowledge, the passing of the Information Quality Law
has not affected the pace or length of rulemakings.

Perception:
The appeals process, the public's opportunity to ask for reconsideration
of a complaint, will not improve anything.

Reality:
Most of the Information Quality responses to requests for correction that
were denied have subsequently been appealed. The majority of the appeals
are still in the process of being answered; thus, it is too early to assess
the value added. However, this added step appears to have fostered corrections.
The appeals process requires independent agency review of the reconsideration
request, its justification, and its strength. We recently saw this process
play out at HHS where, upon appeal, a complaint to the National Toxicology
Program resulted in the discontinuation of the webpage dissemination of
a draft abstract that contained results that were flawed (the compound
tested contained a contaminant that was believed to have influenced the
test results). In this situation, the appeals step was critical in order
for the agency to recognize that a correction was needed.

Perception:
The Information Quality Law is aimed primarily at information in federal
rulemakings.

Reality:
Most complaints that agencies have received have not been directly related
to rulemakings. The correction requests have been directed towards information
that is predominantly disseminated to the public as reports, notices,
or as a means of sharing agency findings on webpages. These disseminations
may eventually lead to regulations at federal, state and local levels,
but the disseminations themselves are not rules nor are they typically
contained in rulemaking notices. This is not surprising, as I have been
told by the OIRA staff that many of the concerns in the previous administration,
which led to the creation of the Information Quality Act, were related
to questionable disseminations of agency information on their websites,
not necessarily via rulemakings.

Perception:
Colleges and Universities are regulated by the Information Quality Law.

Reality:
OMB has heard claims that college professors and their students, if funded
by the federal government, are covered by the Information Quality Law
and agency guidelines. OMB believes this is a misreading of the law. The
Information Quality Act covers only disseminations by federal agencies,
specifically those agencies covered by the Paperwork Reduction Act. The
Law does not cover colleges and universities, even when federal research
funding is involved. More generally, the law covers only agency disseminations,
not disseminations made by third parties (e.g., academics, stakeholders
and the public). As a practical matter, it may nonetheless make sense
for third parties to consider the quality of information that they disseminate
or submit to the federal government. If third-party submissions are to
be used and disseminated by federal agencies, it is the responsibility
of the federal government, under the Information-Quality Act, to make
sure that such information meets relevant information-quality standards.
The agency guidelines establish performance goals and procedures to assist
in the agency's evaluation of all information for which agency dissemination
is under consideration, whether that information was generated by the
agency or by third parties.

OMB's
LEARNING CURVE

We have learned
that passing a statute on information quality is easier than improving
the quality of information. Often complaints hinge on the interpretations
of science or analyses. When dealing with uncertain scientific issues,
it is possible to draw several reasonable inferences depending on the
perspective of the reviewer. Thus more than one plausible answer or methodology
may exist. We are learning that it is possible for neither the agency
nor the requestor to be incorrect. Thus far, the majority of correction
requests have been denied, usually on the basis that a reasonable scientist
could interpret the available information in the way that the agency had.
Such complaints might have been better focused if they had addressed the
inadequate treatment of uncertainty rather than the accuracy of information.

LOOKING
FORWARD

Despite all
the misperceptions, kinks, and surprises, we feel that we are moving closer
to achieving the goals of the Information Quality Act. Agencies are aware
that ensuring the high quality of government information disseminations
is a high priority of the Bush Administration. The next big step will
be to enhance the pre-dissemination procedures making sure that information
is valid before it is disseminated. OMB Peer Review Bulletin has undergone
1) public comment, 2) an NAS workshop, and 3) interagency review. We are
currently considering all the comments we received and are making appropriate
revisions.

The Perils
of Precaution

The concept
of a universal precautionary principle apparently has its origins in early
German and Swedish thinking about environmental policy, particularly the
need for policymakers to practice foresight in order to prevent long range
environmental problems. The concept was included in the Amsterdam Treaty
- an important step toward establishment of the European Union - but the
concept was left undefined and was applied only to environmental policy.
More recently, the EC extended this concept to consumer protection and
public health. Still no formal definition exists and the international
legal status is uncertain.

The United
States Government believes it is important to understand that, notwithstanding
the rhetoric of our European colleagues, there is no such thing as THE
precautionary principle. Indeed, the Swedish philosopher Sandin has documented
19 versions of the precautionary principle in various treaties, laws and
academic writings. Although these versions are similar in some respects,
they have major differences in terms of how uncertain science is evaluated,
how the severity of consequences is considered, and how the costs and
risks of precautionary measures are considered. The United States Government
believes that precaution is a sensible idea but there are multiple approaches
to implementing precaution in risk management.

Given the
ambiguity about the precautionary principle, it may be useful to start
with a dictionary definition. Webster's 2nd Edition of the NEW WORLD DICTIONARY
defines precaution as "care taken beforehand" or "a measure
taken beforehand against possible danger." Understood in this way,
precaution is a well-respected notion that is practiced daily in the stock
market, in medicine, on the highway and in the workplace. In both business
and politics, decision makers seek the right balance between taking risks
and behaving in a precautionary manner.

Before joining
OMB, I served for 17 years on the faculty of the Harvard School of Public
Health. In that capacity I learned that public health historians have
documented the preventable pain and suffering that can occur from insufficient
consideration of the need for precaution. In the United States we felt
that pain as a result of how we handled emerging science about tobacco,
lead and asbestos. Historians teach us that the major health problems
from these substances could have been reduced or prevented altogether
if decision makers had reacted to early scientific indications of harm
in a precautionary manner.

In each of
these examples (tobacco, lead and asbestos), it was epidemiology rather
than the experimental sciences that played the most pivotal role in identifying
health risks. Ironically, it is epidemiology that is now one of the more
controversial contributors to public health science.

There is
no question that postulated hazards sometimes prove more serious and/or
widespread than originally anticipated. Ralph Nader has previously argued
that this is the norm in regulatory science, while the European Commission
recently issued a report of case studies where hazards appear to have
been underestimated. However, the dynamics of science are not so easily
predicted. Sometimes claims of hazard prove to be exaggerated and in fact
there are cases of predictions of doom that have simply not materialized.

Consider
the "dismal theorem" of the Reverend Thomas Malthus (1798).
He hypothesized that population would grow exponentially while sources
of sustenance would only grow arithmetically. The result, he predicted,
would be that living standards would fail to rise beyond subsistence levels.
However, history has shown this theorem to be incorrect. Malthus did not
foresee the technological advances that have allowed both population and
standard of living to risk steadily and substantially.

A more recent
example in the USA concerns the popular artificial sweetener saccharine.
FDA declared the regulatory equivalent of war against this product on
the basis of experimental laboratory test results. The finding was that
huge doses of saccharine cause bladder cancer in rodents. While FDA attempted
to ban saccharine based on this evidence, the US Congress overturned FDA's
action. With the benefit of hindsight, it now appears that FDA's attempted
ban may have been ill-advised. Just recently, the federal government in
the USA removed saccharine from the official list of "carcinogens"
for two reasons: experimental biologists have found that saccharin causes
bladder tumors in rodents through a mechanism (cell proliferation) that
is unlikely to be relevant to low-dose human exposures; and large-scale
epidemiological studies of saccharin users have found no evidence that
the product is linked to excess rates of bladder cancer in people.

Given that
the dynamics of science are not predictable, it is important to consider
the dangers of excessive precaution. One of those is the threat to technological
innovation. As a thought experiment, Imagine it is 1850 and the following
version of the precautionary principle is adopted: no innovation shall
be approved for use until it is proven safe, with the burden of proving
safety placed on the technologist. Under this system, what would have
happened to electricity, the internal combustion engine, plastics, pharmaceuticals,
the Internet, the cell phone and so forth? By its very nature, technological
innovation occurs through a process of trial-and-error and refinement,
and this process could be disrupted by an inflexible version of the precautionary
principle.

Many risk
specialists in the USA regret some of the prior policy steps we have taken
on the basis of precaution. In US energy policy, for example, the Three
Mile Island incident had a large policy impact, though even today there
is no evidence of significant public health harm caused by the accident
at Three Mile Island. In fact, there has been a de facto moratorium on
the construction of new nuclear power plants in the USA. We have become
more deeply dependent on fossil fuels for energy, and now precaution is
being invoked as a reason to enact stricter rules on use of fossil fuels.
Part of the answer may rest with clean coal technologies and renewable
energy but we should not foreclose the advanced nuclear option.

Although
there are many reasons to be skeptical about Europe's stance on precaution,
there are recent signs of progress from Europe. Take the response of Brussels
to "mad cow's disease". Once the British government and industry
had taken all reasonable steps to address this problem, Brussels instructed
Member States of the EU to lift their bans on beef imports from the UK.
All member states complied except France, who argued that French beef
might still be safer than British beef and that France has the right to
invoke the precautionary principle. Brussels took France to the European
Court of Justice, where the Court ruled against France, indicating that
speculative appeals to the precautionary principle must have some grounding
in science.

Much more
recently, the EC actually rejected an unauthorized use of the precautionary
principle by the provincial government of Upper Austria. In March of this
year Austria notified Brussels of its proposed ban of genetically modified
seeds that the EC had approved for cultivation under the EC Directive
90/220. Upper Austria appealed to the precautionary principle but Brussels
overruled them: "Recourse to the precautionary principle presupposes
that potentially dangerous effects . . . have been identified, and that
scientific evaluation does not allow the risk to be determined with sufficient
certainty." The EC noted that Upper Austria had not made this case
and there was certainly nothing unique about the safety of GM seeds in
Upper Austria.

While it
is fashionable to criticize Europe on the subject of precaution, and much
of that criticism is deserved, it should also be noted that the EC's official
views on precaution are becoming more nuanced. In the February 2000 Communication,
for example, we found the following views that are similar to the perspective
of the US government:

1. Precaution is a necessary and useful concept but it is subjective and
susceptible to abuse by policy makers for trade purposes.

2. Scientific and procedural safeguards need to be applied to risk management
decisions based on precaution.

3. Adoption of precautionary measures should be preceded by objective
scientific evaluations, including risk assessment and benefit-cost analysis
of alternative measures.

4. There are a broad range of precautionary measures including bans, product
restrictions, education, warning labels and market-based approaches. Even
targeted research programs to better understand a hazard are a precautionary
measure.

5. Opportunities for public participation - to discuss efficiency, fairness
and other public values - are critical to sound risk management.

In summary, there are two major perils associated with an extreme approach
to precaution. One is that technological innovation will be stifled, and
we all recognize that innovation has played a major role in economic progress
throughout the world. A second peril, more subtle, is that public health
and the environment would be harmed as the energies of regulators and the
regulated community would be diverted from known or plausible hazards to
speculative and ill-founded ones. For these reasons, please do not be surprised
if the US government continues to take a precautionary approach to calls
for adoption of a universal precautionary principle in regulatory policy.

1The
law is Section 515 of the Treasury and General Government Appropriations
Act for Fiscal Year 2001.